Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY

K-Number: K974551 · 1997-12-22

ApplicantSealite Sciences, Inc.
Decision Date1997-12-22
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sealite Sciences, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974551. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY?

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K974551.

When did SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY receive FDA 510(k) clearance?

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974551.

Who is the listed applicant for SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY?

The FDA 510(k) record lists Sealite Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY?

The FDA product code for SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY is CEC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sealite Sciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYK970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAYK970483AQUALITE INTACT PTHK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSHK964925SEALITE SCIENCES, INC. AQUALITE LH

View all 11 devices →

Related Devices (Code: CEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑